In response to the January 7 publication of the USPTO’s “2019 Revised Patent Subject Matter Eligibility Guidance,” St. Louis patent attorneys Doug Robinson, Elisabeth Koral and Leanne Rakers lay out the good news and the bad news for biosimilar makers in a new article for the Biosimilar Development website.
Subject matter eligibility has been an area of frustrating uncertainty at the USPTO for several years. Prior to 2012, the issue was relatively painless to overcome in the patenting process and it was rarely litigated in court. Following the Supreme Court’s decisions in Mayo, Alice and Myriad, however, evaluating patent subject matter eligibility under 35 U.S.C. 101 became a much more ambiguous process. The 2019 Revised Guidance means to improve the situation by providing more consistent and predictable guidelines for patent examiners to follow.
For biosimilar developers, though, the 2019 Revised Guidance offers both an upside and a downside. For the latter, fewer 101 rejections will likely lead to increased patent thickets surrounding biologic innovations and extended protection for existing patents through the so-called “evergreening” process. This could substantially hamper biosimilar growth.
On the upside, greater predictability in the patenting process is highly advantageous for biosimilar developers looking to mitigate risks. In reference to the two-part test the USPTO adapted from the Mayo/Alice test, the 2019 Revised Guidance also provides a new and improved procedure for determining whether a claim is directed to a judicial exception under Step 2A. Rakers, Koral and Robinson describe it as follows:
The revised procedure breaks Step 2A into two prongs: (i) whether the claim recites a judicial exception; and (ii) whether a recited judicial exception is integrated into a practical application. Only when the claim recites a judicial exception and fails to integrate that judicial exception into a practical application, is the claim ‘directed to’ a judicial exception requiring further analysis under Step 2B. In other words, when a claim is deemed to integrate a judicial exception into a practical application, that claim qualifies as eligible subject matter.
The expected overall effect of the 2019 Revised Guidance is the USPTO will issue more, not fewer, patents. Biosimilar companies will therefore be wise to closely monitor patent thickets in the biologics space. They will also want to tread carefully in any new 101 challenges, as a win in one case — arguing an antibody is ineligible, for example — could lead to tremendous losses for the overall industry if a large swath of patents are put on the chopping block.
Another important takeaway from the 2019 Revised Guidance is that it does not bind district court or appellate court judges. In a recent nonprecedential decision, however, the Federal Circuit signaled that it is not bound by the USPTO’s guidance (Cleveland Clinic Foundation v. True Health Diagnostics LLC).